When was the last time you gave serious thought to the quality of water your pharmacies use for reconstitution and compounding? If you do have a water quality program in place, how do you know it’s really working? If you answered “rarely” or “never” to the first question, and “I don’t know” to the second, you’re not alone. Most pharmacy owners and operators don’t have the slightest idea about the condition of their water filtration systems, water dispensing devices, and overall water quality. FillPure changes that.
At FillPure, our mission is to not only ensure the purified water your pharmacies use for reconstitution and compounding meets or exceeds USP quality standards, but also give you the peace of mind to know that your customers are getting the very best product possible.
We do this by automating water filtration system maintenance with a yearly store visit by a FillPure employed and trained technician. During this visit, the FillPure technician performs and/or records the following:
- Tests for total dissolved solids (TDS)
- Test for bacteria
- Filtration system sanitization
- Filter and membrane replacement
- Hardware repairs or replacement
- Water dispenser calibration and cleaning
- Pharmacy team training
Total Dissolved Solids (TDS) measurements are used to assess the performance of your reverse osmosis (RO) water filtration system. A well-maintained RO system will generally reduce incoming TDS by 80% or more. TDS is also a gauge of water quality. As a general rule of thumb, TDS levels should be at or below 50ppm for water used for reconstitution.
Bacteria tests are performed on-site to ensure there are no potentially harmful bacteria going into customers’ medications. Should a test come back positive for the presence of bacteria, our technicians will advise your staff to stop the use of the filtration system and water dispenser and will immediately notify a senior FillPure representative for follow-up.
An essential component of the FillPure program is access to the FillPure Portal. This web-based platform gives you real-time visibility to the work being done in your stores, including results from TDS and bacteria tests and photos from each store. You’ll also receive automatic alerts on any issues that require immediate action, like broken water pipes or heavily clogged sink drains.
This level of transparency is unprecedented in the industry. Not only are you getting the firsthand guarantee the work has been performed to your satisfaction, any issues that will affect water quality can be quickly identified and fixed. For more information on the FillPure Portal, click here.
The following USP guidelines apply to water used for reconstitution and non-sterile compounding.
The minimal quality of source or feed water for the production of Purified Water is drinking water. This source water may be purified using unit operations that include deionization, distillation, ion exchange, reverse osmosis, filtration, or other suitable purification procedures. Purified water systems must be validated to reliably and consistently produce and distribute water of acceptable chemical and microbiological quality. Purified water systems that function under ambient conditions are particularly susceptible to the establishment of tenacious bioorganisms, which can be the source of undesirable levels of microorganisms or endotoxins in the effluent water. These systems require frequent sanitization and microbiological monitoring to ensure water of appropriate microbiological quality at the points of use.
Purified water (see purified water monograph) shall be used for compounding non-sterile drug preparations when formulations indicate the inclusion of water.